Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

Background to PMSR

The intention behind the introduction of PMSR is to improve risk management in relation to, and the containment of safety issues arising from, medical devices and in-vitro diagnostic medical devices put on the market in Great Britain (England, Scotland and Wales) in a manner proportionate to the risks posed by the device. The new post-market surveillance measures under PMSR are similar (but not identical) to those which apply in the EU, and Northern Ireland, under the EU Medical Device Regulation 2017/745 (EU MDR) and EU In Vitro Diagnostic Medical Device Regulation 2017/746 (EU IVDR).

Post-market surveillance requirements

We have written in detail previously on the new requirements under PMSR. To recap, they include obligations on medical device manufacturers to:

1. maintain a “PMS System” and a “PMS Plan” to ensure the collection of relevant data on the safety of each device placed on the market in Great Britain in order to spot trends and identify the potential need for corrective action;
2. periodically submit to the MHRA a “PMS Report” for lower risk devices or “Periodic Safety Update Report” (PSUR) for higher risk devices summarising the findings from the PMS Plan and any corrective action taken in relation to the device; and
3. take certain steps when investigating and responding to serious incidents involving the device, including by taking corrective action or issuing a field safety notice (FSN). 

MHRA guidance on PMSR 

In order to assist medical device manufacturers in their preparations for the introduction of PMSR, the MHRA has published various guidance including guidance specifically aimed at assisting manufacturers in: (1) complying with their new vigilance and reporting obligations; and (2) navigating the Manufacturers online reporting environment (MORE).

Beyond the PMS Plan: adverse incident preparedness

Manufacturers with medical devices on the market in Great Britain will have been preparing for compliance with the core obligations under PMSR (e.g., the requirement to create a PMS Plan) for at least the past six months. However, now PMSR is in force, some manufacturers may still benefit from reviewing their preparedness with respect to some of the contingent obligations which will arise in the event of a serious incident relating to a medical device.

The checklist below sets out five actions to assist medical device manufacturers in being equipped to respond to a serious incident in relation to a device: 

1. Get set-up on MORE

   The MHRA will only accept reports relating to adverse incidents for devices occurring in Great Britain or Northern Ireland if they are submitted via MORE. For Great Britain, there are specific reporting forms available. For Northern Ireland, incident reports should be submitted using the EU forms which are available on MORE (noting that the MHRA is still the competent authority for medical devices placed on the market in Northern Ireland). All medical device manufacturers and their representatives can register for an account on MORE. However, larger manufacturers may benefit from discussing the potential to set-up an API between their internal IT systems to the MHRA’s IT systems.

2. Review the MHRA’s vigilance guidance

   In January 2025, the MHRA published Guidance providing examples of incidents to report under the PMSR vigilance system. This guidance was supplemented by device-specific guidance for certain categories of medical device (including blood glucose meters, joint replacement implants, neurostimulators and software as a medical device) which gives further detail on which incidents are reportable as individual incidents and/or in the PSUR.

3. Determine an FSN distribution strategy for Great Britain 

   Under PMSR, manufacturers must take all reasonable steps to ensure that FSNs are sent to users of the device. PMSR/the MHRA does not stipulate the manner in which FSNs should be sent but the MHRA expects manufacturers to take steps to verify that FSNs have been received, read and acted upon by the recipient. Under the MHRA’s Guidance on Field safety notices it is insufficient for FSNs to be sent via email with read receipts enabled, or via recorded mail, as this evidences delivery but not that the FSN has been read and acted upon. The MHRA refers to medical device manufacturers who use require an e-signature as confirmation from the recipient that the FSN has been received and acted on.

   Medical device manufacturers should consider their optimal strategy for distributing FSNs in Great Britain based on the nature of their device, customer base and supply chain, which may not be identical to that for the EU given differences between the UK and European healthcare systems and between UK MDR and EU MDR. Questions that may assist in determining the best FSN strategy include:

   • Can you quickly identify your end-customers, including where you have appointed a distributor (see further on this topic under 5. below)?
   • Can you make use of the network MHRA-registered medical device safety officers (MDSOs) to distribute FSNs? 95% of NHS Trusts have at least one MDSO and the MHRA has identified MDSOs as a powerful resource to achieve target reconciliation of responses to FSNs.
   • If your medical device is software-based, does it include functionality that would help you to distribute FSNs and ensure that they are acted upon?
   • Should the FSN be published via any specialised news media?
4. Pre-prepare the details for an FSN

   The MHRA makes available a template FSN with drafting guidance. However, all FSNs will need to be tailored with details of the device and the safety issue. Much of the content in part 1 of the template FSN relating to the device itself can be prepared in advance. The MHRA notes that common issues with FSNs include a failure to use plain, simple language (i.e. too much jargon), missing UK contact details and acknowledgement forms and poor translations. Most of these issues could be addressed through advance preparation.

5. Embed good traceability practices with distributors now

The MHRA’s Guidance on Field safety notices reminds medical device manufacturers that they should keep records to help them to trace their distributed product. This extends to ensuring that the manufacturer’s contracts oblige its distributors to keep onward traceability records of sales to end users.

At present, UK MDR does not contain some of the traceability requirements which were introduced under EU MDR, including: (a) direct obligations on distributors to report complaints received in relation to a medical device to the manufacturer and/or to the MHRA; or (b) requirements for each medical device to carry a unique device identifier. However, further anticipated reforms to UK MDR are expected to introduce these requirements.

We regularly see distribution agreements and terms and conditions of sale for medical devices which do not contain robust reporting obligations. Given the introduction of PMSR, as well as the anticipated introduction of comparable obligations relating to the traceability of medical devices (see “Next steps” below), now is a good time for medical manufacturers to review their contracts to ensure they include appropriate downstream traceability and reporting requirements.

Authored by Jane Summerfield and Bea Watts.